Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia: a Randomized Controlled Trial.

University of Bari1 个研究点分布在 1 个国家目标入组 362 人开始时间: 2020年1月14日最近更新: 2021年1月12日

适应症

干预措施

试验速览

阶段: 3 期
发起方
入组人数: 362
试验地点: 1
主要终点: Eradication rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

详细描述

Study design:

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

盲法说明

Investigators performing urea breath test 30 days after the end of the treatment (assessment of the primary outcome: eradication rate) will not be aware of participants' allocation and received therapy. Moreover, two independent investigators will perform RT-PCR on stool samples and gastric biopsy specimens, blinded to the other test results.

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•presence of dyspeptic symptoms, according to Rome IV criteria;
•Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology);
•naive to Helicobacter pylori treatment;
•written informed consent.

排除标准

•previous Helicobacter pylori treatment;
•diagnosis of gastric cancer or other diseases requiring surgery;
•contraindications to upper endoscopy;
•chronic diarrhea;
•known allergy to any drugs used in the intervention and control arm.

研究组 & 干预措施

Tailored therapy

Experimental

Clarithromycin-sensitive strain (10 day-therapy):

Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Clarithromycin 500 mg bid (tablet) Metronidazole 500 mg bid (tablet) 2. Clarithromycin-resistant and tetracycline-sensitive strain (10 day-therapy):

Pantoprazole 40 mg bid (tablet) Tetracycline 125 mg + metronidazole 125 mg + bismuth 140 mg in a single tablet (3 tablets qid) 3. Clarithromycin- and tetracycline-resistant and levofloxacin-sensitive strain (10 day- therapy):

Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Levofloxacin 500 mg bid (tablet) 4. Clarithromycin-, tetracycline- and levofloxacin-resistant strain (10 day-therapy):